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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03491553




Registration number
NCT03491553
Ethics application status
Date submitted
2/04/2018
Date registered
9/04/2018

Titles & IDs
Public title
Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B
Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Antiviral Activity of GS-9688 in Virally-Suppressed Adult Subjects With Chronic Hepatitis B
Secondary ID [1] 0 0
ACTRN12618000143224p
Secondary ID [2] 0 0
GS-US-389-2024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Selgantolimod
Treatment: Drugs - Placebo
Treatment: Drugs - Hepatitis B virus (HBV) OAV Therapy

Experimental: Selgantolimod 3 mg: HBeAg-positive CHB Participants - Participants with Hepatitis B e Antigen (HBeAg)-positive CHB will remain on their current OAV and receive selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants can continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.

Experimental: Selgantolimod 3 mg: HBeAg-negative CHB Participants - Participants with HBeAg-negative CHB will remain on their current OAV and receive selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Experimental: Selgantolimod 1.5 mg: HBeAg-positive CHB Participants - Participants with HBeAg-positive CHB will remain on their current OAV and receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Experimental: Selgantolimod 1.5 mg: HBeAg-negative CHB Participants - Participants with HBeAg-negative CHB will remain on their current OAV and receive selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Experimental: Placebo: HBeAg-positive CHB Participants - Participants with HBeAg-positive CHB will remain on their current OAV and receive 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.

Experimental: Placebo: HBeAg-negative CHB Participants - Participants with HBeAg-negative CHB will remain on their current OAV and receive 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants will continue their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants can continue in the TFFU phase for up to an additional 48 weeks.


Treatment: Drugs: Selgantolimod
Tablet(s) administered orally once weekly

Treatment: Drugs: Placebo
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly

Treatment: Drugs: Hepatitis B virus (HBV) OAV Therapy
Commercially available HBV OAV therapy could include one of the following:

Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With = 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants With = 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4
Timepoint [1] 0 0
Week 4
Secondary outcome [2] 0 0
Percentage of Participants With = 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
Percentage of Participants With = 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants With = 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Change From Baseline in Serum qHBsAg at Week 4
Timepoint [5] 0 0
Baseline, Week 4
Secondary outcome [6] 0 0
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8
Timepoint [6] 0 0
Baseline, Week 8
Secondary outcome [7] 0 0
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12
Timepoint [7] 0 0
Baseline, Week 12
Secondary outcome [8] 0 0
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24
Timepoint [8] 0 0
Baseline, Week 24
Secondary outcome [9] 0 0
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48
Timepoint [9] 0 0
Baseline, Week 48
Secondary outcome [10] 0 0
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Percentage of Participants With HBsAg Loss at Week 24
Timepoint [11] 0 0
Week 24
Secondary outcome [12] 0 0
Percentage of Participants With HBsAg Loss at Week 48
Timepoint [12] 0 0
Week 48
Secondary outcome [13] 0 0
Percentage of Participants With HBeAg Loss and Seroconversion at Week 12
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
Timepoint [14] 0 0
Week 24
Secondary outcome [15] 0 0
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
Timepoint [15] 0 0
Week 48
Secondary outcome [16] 0 0
Percentage of Participants With Virologic Breakthrough
Timepoint [16] 0 0
Baseline up to Week 48
Secondary outcome [17] 0 0
Percentage of Participants With Drug Resistance Mutations
Timepoint [17] 0 0
Baseline up to Week 48

Eligibility
Key inclusion criteria
Key

* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* Adult males and non-pregnant, non-lactating females
* Documented evidence of chronic HBV infection with detectable hepatitis B surface antigen (HBsAg) levels
* On commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening
* HBV Deoxyribonucleic acid (DNA) = 20 IU/mL for 6 or more months prior to screening
* Screening Electrocardiogram (ECG) without clinically significant abnormalities

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Extensive bridging fibrosis or cirrhosis
* Adults meeting any of the protocol defined exclusionary laboratory parameters at screening:

* Alanine aminotransferase (ALT) > 3x Upper Limit of Normal (ULN)
* International normalized ratio (INR) > ULN unless the adult is stable on an anticoagulant regimen
* Albumin < 3.5 g/dL
* Direct bilirubin > 1.5x ULN
* Platelet Count < 100,000/uL
* Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method)
* Co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus
* Prior history of hepatocellular carcinoma (HCC) or screening alpha-fetoprotein = 50 ng/mL without imaging
* Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed.
* Chronic liver disease of a non-HBV etiology, except for non-alcoholic fatty liver disease
* Received solid organ or bone marrow transplant
* Received prolonged therapy with immunomodulators or biologics within 3 months of screening
* Use of another investigational agent within 90 days of screening, unless allowed by the Sponsor

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/08/2020
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT03491553